# K212155: TheraFace LED

- Pathway: 510(k) (Traditional)
- Applicant: Theragun, Inc.
- Decided: Dec 21, 2021 after 162 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 158 ancestors in all.
42 later devices descend from it; 2 cite it directly.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171821: 2 Face / Face Evolution, Heat IN A Click (2018) Summary page 4.
- K162489: RED Light Device, Zhongshan Bisen Plastic Electronic Products Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), 39 descendants of its own
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own
- K241102: Luna 4 plus (2024), 5 descendants of its own
- K242385: LED Therapy Mask (MN1, M226) (2025), 3 descendants of its own

## Indications for use
The device can work in multiple function modes as following with different indication for use: 1) The red light is intended to treat periorbital wrinkles. 2) The blue light is intended to treat mild to moderate inflammatory acne. 3) The Red + IR is intended to treat periorbital wrinkles.

Source page: https://510kreport.com/device/K212155
Methodology: https://510kreport.com/methodology